ComplicationsSICANCT01343069
Safety Improvement and Checklist Application
A study testing implementation surgical checklist in people with Complications and Outcome, run by Regional Hospital of Bolzano.
Trial summary
The study investigates the impact of the introduction of a surgical checklist on the incidence of complications and mortality within 30 days after surgery in patients scheduled for elective non-cardiac surgery. Patients scheduled for elective surgical procedures lasting longer than 20 minutes at are eligible. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complications, Outcome
- What is being tested?
- implementation surgical checklist
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- elective surgery in general or regional anesthesia lasting > 15 min
Who cannot join
- urgent surgery
About this study
Official title: Safety Analysis in Regard to the Introduction of Surgical Checklists in the Operation Rooms in a Tertiary Care Center
The study investigates the impact of the introduction of a surgical checklist on the incidence of complications and mortality within 30 days after surgery in patients scheduled for elective non-cardiac surgery. Patients scheduled for elective surgical procedures lasting longer than 20 minutes at are eligible. Surgery is performed in a single tertiary care center. Study design is an open trial before and after intervention (implementation of the checklist "safe surgery saves lifes").
- Conditions
- Complications, Outcome
- Being tested
- implementation surgical checklist
- Keywords
- safety, team, team performance, surgery, outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implementation surgical checklistProcedure or surgery
a checklist according to the suggestions raised by the WHO is implementated
| Study group | Role | What they receive |
|---|---|---|
| before surgical checklist | No intervention | Not described |
| after implementation surgical checklist | Active comparator | Not described Receives: Procedure: implementation surgical checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of complications after elective surgery
comparison of number of complications in the two study arms before and after introduction of the checklist
Measured: within 30 days
Secondary outcomes (1)
mortality
evaluation of 30-days mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startJun 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Why it stopped: insufficient quality of data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital of Bolzano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Bock, Regional Hospital of Bolzano
- Investigators
- Matthias Bock, MD, Study director, Central Hospital Bolzano Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343069
- Sponsor's protocol ID
- check4outcome2
- Acronym
- SICA
- Status last verified
- May 2015
- First submitted
- 26 Apr 2011
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Analysis in Regard to the Introduction of Surgical Checklists in the Operation Rooms in a Tertiary Care Center
- ClinicalTrials.gov ID
- NCT01343069
- Acronym / sponsor ID
- SICA / check4outcome2
- Conditions
- Complications, Outcome
- Keywords
- safety, team, team performance, surgery, outcome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: insufficient quality of data
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Regional Hospital of BolzanoUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 27 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates the impact of the introduction of a surgical checklist on the incidence of complications and mortality within 30 days after surgery in patients scheduled for elective non-cardiac surgery. Patients scheduled for elective surgical procedures lasting longer than 20 minutes at are eligible. Surgery is performed in a single tertiary care center. Study design is an open trial before and after intervention (implementation of the checklist "safe surgery saves lifes").
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| before surgical checklist | No intervention | – |
| after implementation surgical checklist | Active comparator | Procedure: implementation surgical checklist |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- elective surgery in general or regional anesthesia lasting > 15 min
Key exclusion criteria (1 listed)
- urgent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implementation surgical checklista checklist according to the suggestions raised by the WHO is implementated | Procedure or surgery | after implementation surgical checklist |
Primary outcome
number of complications after elective surgery
Time frame: within 30 days
comparison of number of complications in the two study arms before and after introduction of the checklist
1 secondary outcome
mortality
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Bock, MD study director
Central Hospital Bolzano Italy
Questions about this trial
What is this clinical trial studying?
A study testing implementation surgical checklist in people with Complications and Outcome, run by Regional Hospital of Bolzano.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of complications after elective surgery (time frame: within 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.